Patients Treated by Radiotherapy With < One Gy to the BrainCogRadNCT01960751

Long Term Neurocognitive Effects of Low-dose Radiation in the Brain: Study of 150 Patients in the French Hemangioma Cohort

A study testing neurocognitive tests battery in people with Patients Treated by Radiotherapy With < One Gy to the Brain, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Context: Studies that address specifically the neurocognitive consequences that can be caused by low-dose radiation receiving during the childhood have still to be performed. In this issue, we focus on an investigation with patients who have received radiotherapy for a benign tumor (skin hemangioma), in France. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Patients Treated by Radiotherapy With < One Gy to the Brain
What is being tested?: neurocognitive tests battery
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteFrance
Study dates: 14 Apr 2014to 4 Feb 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject treated by radiotherapy for a skin hemangioma in childhood at Gustave Roussy between 1941 and 1973 and who have received less than 1 Gy of radiation doses in the brain
Inhabitants of Île-de-France
French medical insurance
Good knowledge and understanding of the French language
Non-inclusion Criteria
Cerebral hemangioma

Show all 12Show fewer

Syndrome genetic predisposition
Pregnant woman
Private person of liberty or under guardianship
Radiation dose to the brain greater than 1 Gy during radiotherapy treatment of skin hemangioma
Chemotherapy during skin hemangioma treatment
Inability to undergo counseling for geographical reasons

Who cannot join

Pregnancy
Inability to perform neurocognitive tests battery for medical reasons

Trial locations and contacts

1 site in 1 country.

France1 site

Gustave Roussy
Villejuif

Other trials in France

About this study

Official title: Etude Des séquelles Neurocognitives à Long Terme Des Faibles Doses de Radiation Chez 150 Patients traités Par radiothérapie Dans l'Enfance Pour un hémangiome cutané à l'Institut Gustave Roussy (IGR) Entre 1941 et 1973

Patients and methods: More than 8300 children with a skin hemangioma were treated at Gustave Roussy (Île-de-France) from 1941 to 1973 and a number of them have received radiotherapy. These patients have been treated and followed by Gustave Roussy, so their clinical records can be tracked with great accuracy and the ionizing radiation dose to the brain have been estimated. From this patient cohort, the aim is to evaluate neurocognitive dysfunction or disorder that can be caused by low-dose radiation to the brain (less than one Gray (Gy)). A total of 150 patients is expected. They will be contacted by letter to explain the purpose and methods of carrying out tests. Two groups will be analysed according to the received ionizing radiation dose to the brain during the radiotherapy (exposed: 0.05 to 1 Gy, vs unexposed: less than 0.05 Gy). Tests exploring several cognitive functions (memory, arithmetic, orientation, etc.) will be used.

Expected results: We expect to describe the potential neurocognitive dysfunction or disorder and to identify risk factors and brain structures whose lesions are responsible for the neurocognitive dysfunction or disorder.

A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive dysfunction or disorder.

Read the detailed description

CogRad is an interventional study designed within the European project called Cognitive and Cerebrovascular Effects Induced by Low Dose Ionizing Radiation (CerebRad).

CerebRad is a collaborative European project funded in 2011 within the 7th European Union (EU) framework programme, Nuclear Fission and Radiation Protection. CerebRad aims to identify the potential cognitive and cerebrovascular risks of radiation doses below 100 milliGray (mGy) when delivered to a young child (pre- or postnatally).

Conditions: Patients Treated by Radiotherapy With < One Gy to the Brain
Being tested: neurocognitive tests battery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

neurocognitive tests batteryOther
Also called - MMSE, - SDS, - SF-36, - HAD
The two groups (exposed: 0.05 to 1 Gy; unexposed: less than 0.05 Gy) will receive the same neurocognitive tests battery.

Study groups in NCT01960751
Study group	Role	What they receive
neurocognitive tests	Other	neurocognitive tests battery (MMSE, SDS, SF-36, HAD, BPRS, RAVLT, FACT-Cog, MoCA) Receives: Other: neurocognitive tests battery

What is being measured

The primary outcome is the main question the study is designed to answer.

All neurocognitive dysfunction or disorder on adults measured by means of eight tests
The score to the 8 tests will be correlate with the presence of neurocognitive dysfunction or disorder
Measured: Participants will be tested for the duration of hospital stay (half a day).The neurocognitive tests battery will be carry out 56 years on average after exposure to low-dose radiation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Apr 20144 Feb 2015

First posted11 Oct 2013 (estimated)
Study start14 Apr 2014
Primary completion4 Feb 2015
Study completion4 Feb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Patients Treated by Radiotherapy With < One Gy to the BrainStudies of the same condition, open and under way.
More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Enrolment: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01960751
Sponsor's protocol ID: C13-01
Other IDs: 2013-A00513-42
Acronym: CogRad
Status last verified: Jan 2025
First submitted: 7 Aug 2013
Last updated: 23 Apr 2026
Results posted: No
Data monitoring committee: No

Publications

Fragu P, Lemarchand-Venencie F, Benhamou S, Francois P, Jeannel D, Benhamou E, Sezary-Lartigau I, Avril MF. Long-term effects in skin and thyroid after radiotherapy for skin angiomas: a French retrospective cohort study. Eur J Cancer. 1991;27(10):1215-22. doi: 10.1016/0277-5379(91)90084-q.
PubMed 1835589
Ron E, Modan B, Boice JD Jr, Alfandary E, Stovall M, Chetrit A, Katz L. Tumors of the brain and nervous system after radiotherapy in childhood. N Engl J Med. 1988 Oct 20;319(16):1033-9. doi: 10.1056/NEJM198810203191601.
PubMed 3173432
Little MP, Hawkins MM, Shore RE, Charles MW, Hildreth NG. Time variations in the risk of cancer following irradiation in childhood. Radiat Res. 1991 Jun;126(3):304-16.
PubMed 2034788
Hall P, Adami HO, Trichopoulos D, Pedersen NL, Lagiou P, Ekbom A, Ingvar M, Lundell M, Granath F. Effect of low doses of ionising radiation in infancy on cognitive function in adulthood: Swedish population based cohort study. BMJ. 2004 Jan 3;328(7430):19. doi: 10.1136/bmj.328.7430.19.
PubMed 14703539
Haddy N, Andriamboavonjy T, Paoletti C, Dondon MG, Mousannif A, Shamsaldin A, Doyon F, Labbe M, Robert C, Avril MF, Fragu P, Eschwege F, Chavaudra J, Schvartz C, Lefkopoulos D, Schlumberger M, Diallo I, de Vathaire F. Thyroid adenomas and carcinomas following radiotherapy for a hemangioma during infancy. Radiother Oncol. 2009 Nov;93(2):377-82. doi: 10.1016/j.radonc.2009.05.011. Epub 2009 Jun 8.
PubMed 19515442
Haddy N, Mousannif A, Paoletti C, Dondon MG, Shamsaldin A, Doyon F, Avril MF, Fragu P, Labbe M, Lefkopoulos D, Chavaudra J, Robert C, Diallo I, de Vathaire F. Radiotherapy as a risk factor for malignant melanoma after childhood skin hemangioma. Melanoma Res. 2012 Feb;22(1):77-85. doi: 10.1097/CMR.0b013e32834dcff1.
PubMed 22082956
Haddy N, Dondon MG, Paoletti C, Rubino C, Mousannif A, Shamsaldin A, Doyon F, Labbe M, Robert C, Avril MF, Demars R, Molinie F, Lefkopoulos D, Diallo I, de Vathaire F. Breast cancer following radiotherapy for a hemangioma during childhood. Cancer Causes Control. 2010 Nov;21(11):1807-16. doi: 10.1007/s10552-010-9607-5. Epub 2010 Jul 7.
PubMed 20607383
Dondon MG, de Vathaire F, Shamsaldin A, Doyon F, Diallo I, Ligot L, Paoletti C, Labbe M, Abbas M, Chavaudra J, Avril MF, Fragu P, Eschwege F. Cancer mortality after radiotherapy for a skin hemangioma during childhood. Radiother Oncol. 2004 Jul;72(1):87-93. doi: 10.1016/j.radonc.2004.03.011.
PubMed 15236880
Ligot L, Diallo I, Shamsaldin A, Chavaudra J, BonaIti-Pellie C, de Vathaire F. Individualized phantom based on CT slices and auxological data (ICTA) for dose estimations following radiotherapy for skin haemangioma in childhood. Radiother Oncol. 1998 Dec;49(3):279-85. doi: 10.1016/s0167-8140(98)00099-1.
PubMed 10075261

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Etude Des séquelles Neurocognitives à Long Terme Des Faibles Doses de Radiation Chez 150 Patients traités Par radiothérapie Dans l'Enfance Pour un hémangiome cutané à l'Institut Gustave Roussy (IGR) Entre 1941 et 1973
ClinicalTrials.gov ID: NCT01960751
Acronym / sponsor ID: CogRad / C13-01
Conditions: Patients Treated by Radiotherapy With < One Gy to the Brain
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, FranceOther government
Collaborators: European Commission, Gustave Roussy, Cancer Campus, Grand Paris
Study start: 14 Apr 2014 (actual)
Primary completion: 4 Feb 2015 (actual)
Study completion: 4 Feb 2015 (actual)
First posted: 11 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A therapeutic treatment will be proposed in the eventuality of screening of a neurocognitive dysfunction or disorder.

Detailed description

CogRad is an interventional study designed within the European project called Cognitive and Cerebrovascular Effects Induced by Low Dose Ionizing Radiation (CerebRad).

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Number of arms: 1

Arm	Type	Receives
neurocognitive tests	Other	Other: neurocognitive tests batteryneurocognitive tests battery (MMSE, SDS, SF-36, HAD, BPRS, RAVLT, FACT-Cog, MoCA)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Subject treated by radiotherapy for a skin hemangioma in childhood at Gustave Roussy between 1941 and 1973 and who have received less than 1 Gy of radiation doses in the brain
Inhabitants of Île-de-France
French medical insurance
Good knowledge and understanding of the French language
Non-inclusion Criteria

Key exclusion criteria (2 listed)

Pregnancy
Inability to perform neurocognitive tests battery for medical reasons

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
neurocognitive tests batteryAlso: - MMSE, - SDS, - SF-36, - HADThe two groups (exposed: 0.05 to 1 Gy; unexposed: less than 0.05 Gy) will receive the same neurocognitive tests battery.	Other	neurocognitive tests

Primary outcome

All neurocognitive dysfunction or disorder on adults measured by means of eight tests
Time frame: Participants will be tested for the duration of hospital stay (half a day).The neurocognitive tests battery will be carry out 56 years on average after exposure to low-dose radiation.
The score to the 8 tests will be correlate with the presence of neurocognitive dysfunction or disorder

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
Background: PubMed 1835589Fragu P, Lemarchand-Venencie F, Benhamou S, Francois P, Jeannel D, Benhamou E, Sezary-Lartigau I, Avril MF. Long-term effects in skin and thyroid after radiotherapy for skin angiomas: a French retrospective cohort study. Eur J Cancer. 1991;27(10):1215-22. doi: 10.1016/0277-5379(91)90084-q.
Background: PubMed 3173432Ron E, Modan B, Boice JD Jr, Alfandary E, Stovall M, Chetrit A, Katz L. Tumors of the brain and nervous system after radiotherapy in childhood. N Engl J Med. 1988 Oct 20;319(16):1033-9. doi: 10.1056/NEJM198810203191601.
Background: PubMed 2034788Little MP, Hawkins MM, Shore RE, Charles MW, Hildreth NG. Time variations in the risk of cancer following irradiation in childhood. Radiat Res. 1991 Jun;126(3):304-16.
Background: PubMed 14703539Hall P, Adami HO, Trichopoulos D, Pedersen NL, Lagiou P, Ekbom A, Ingvar M, Lundell M, Granath F. Effect of low doses of ionising radiation in infancy on cognitive function in adulthood: Swedish population based cohort study. BMJ. 2004 Jan 3;328(7430):19. doi: 10.1136/bmj.328.7430.19.
Background: PubMed 19515442Haddy N, Andriamboavonjy T, Paoletti C, Dondon MG, Mousannif A, Shamsaldin A, Doyon F, Labbe M, Robert C, Avril MF, Fragu P, Eschwege F, Chavaudra J, Schvartz C, Lefkopoulos D, Schlumberger M, Diallo I, de Vathaire F. Thyroid adenomas and carcinomas following radiotherapy for a hemangioma during infancy. Radiother Oncol. 2009 Nov;93(2):377-82. doi: 10.1016/j.radonc.2009.05.011. Epub 2009 Jun 8.
Background: PubMed 22082956Haddy N, Mousannif A, Paoletti C, Dondon MG, Shamsaldin A, Doyon F, Avril MF, Fragu P, Labbe M, Lefkopoulos D, Chavaudra J, Robert C, Diallo I, de Vathaire F. Radiotherapy as a risk factor for malignant melanoma after childhood skin hemangioma. Melanoma Res. 2012 Feb;22(1):77-85. doi: 10.1097/CMR.0b013e32834dcff1.
Background: PubMed 20607383Haddy N, Dondon MG, Paoletti C, Rubino C, Mousannif A, Shamsaldin A, Doyon F, Labbe M, Robert C, Avril MF, Demars R, Molinie F, Lefkopoulos D, Diallo I, de Vathaire F. Breast cancer following radiotherapy for a hemangioma during childhood. Cancer Causes Control. 2010 Nov;21(11):1807-16. doi: 10.1007/s10552-010-9607-5. Epub 2010 Jul 7.
Background: PubMed 15236880Dondon MG, de Vathaire F, Shamsaldin A, Doyon F, Diallo I, Ligot L, Paoletti C, Labbe M, Abbas M, Chavaudra J, Avril MF, Fragu P, Eschwege F. Cancer mortality after radiotherapy for a skin hemangioma during childhood. Radiother Oncol. 2004 Jul;72(1):87-93. doi: 10.1016/j.radonc.2004.03.011.
Background: PubMed 10075261Ligot L, Diallo I, Shamsaldin A, Chavaudra J, BonaIti-Pellie C, de Vathaire F. Individualized phantom based on CT slices and auxological data (ICTA) for dose estimations following radiotherapy for skin haemangioma in childhood. Radiother Oncol. 1998 Dec;49(3):279-85. doi: 10.1016/s0167-8140(98)00099-1.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chiraz EL-FAYECH study director

Gustave Roussy, France

Florent DE VATHAIRE study director

Institut National de la Santé Et de la Recherche Médicale, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All neurocognitive dysfunction or disorder on adults measured by means of eight tests (time frame: Participants will be tested for the duration of hospital stay (half a day).The neurocognitive tests battery will be carry out 56 years on average after exposure to low-dose radiation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01960751, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.